Type:10 Tablets
Generic Name:Pirfenidone
Manufacturer:Incepta Pharmaceuticals Ltd.
Price:৳1250.00
Idiopathic pulmonary fibrosis (IPF)
Should be taken with food: Take w/ food to reduce the possibility of nausea & dizziness. Swallow whole w/ water. Take doses at same time each day.
Idiopathic Pulmonary Fibrosis Initial dose titration Days 1-7: 267 mg (1 capsule) PO TID Days 8-14: 534 mg (2 capsules) PO TID Day 15 and thereafter: 801 mg (3 capsules) PO TID Maintenance dose 801 mg (3 capsules) PO TID with food Not to exceed 2403 mg/day (9 capsules/day) Hepatic impairment Mild-to-moderate (Child Pugh A or B): Use caution; monitor and consider dosage modification or discontinuation as needed Severe (Child Pugh C): Not recommended (not studied)
Safety and efficacy not established
Renal impairment Mild, moderate, or severe: Use caution; monitor and consider dosage modification or discontinuation as needed ESRD requiring dialysis: No recommended (not studied)
Hypersensitivity. History of angioedema. Severe hepatic & renal impairment or end stage liver & renal disease. Concomitant use w/ fluvoxamine.
Precise mechanism by which pirfenidone may work in pulmonary fibrosis has not been established Inhibits transforming growth factor (TGF)-beta, a chemical mediator that controls many cell functions including proliferation and differentiation Also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation
Hepatic function abnormalities, hepatic impairment, photosensitivity reaction or rash, angioedema, dizziness, fatigue & wt loss. May affect ability to drive or operate machinery. Avoid use in pregnancy & lactation.
>10% Nausea (36%),Rash (30%),Upper respiratory tract infection (27%),Diarrhea (26%),Abdominal pain (24%),Headache (22%),Dyspepsia (19%),Dizziness (18%),Vomiting (13%),GERD (11%),Sinusitis (11%) 1-10% Insomnia (10%),Weight decreased (10%),Arthralgia (10%),Photosensitivity (9%),Decreased appetite (8%),Pruritus (8%),Asthenia (6%),Dysgeusia (6%),Noncardiac chest pain (5%),AST/ALT ≥3 x ULN (3.7%) <1% AST/ALT ≥10 x ULN (0.3%)
Data in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage.
Inhibition of CYP1A2 w/ concomitant grapefruit juice. Increased exposure w/ fluvoxamine & other strong & selective CYP1A2 inhibitors, ciprofloxacin, amiodarone, propafenone. Potential to induce hepatic enzyme production by smoking. Lowered plasma levels w/ omeprazole, rifampicin.
